About the role
Quality Engineer – Medical Device Manufacturer
Well-established manufacturer serving the medical device industry is looking for a Quality Engineer to join their team in the greater Rochester, NY area. You'll play a key role in maintaining and advancing quality systems within an FDA regulated manufacturing environment. This is a hands-on position for someone who enjoys owning validation work end-to-end and being a trusted technical resource on the plant floor.
What You'll Do
- Develop and/or execute IQ/OQ/PQ and process-validation protocols
- Support and help lead internal quality audits; serve as a technical resource during external/regulatory audits
- Drive root cause investigations and CAPA activities
- Apply statistical tools (e.g., process capability analysis) to monitor and improve process performance
- Author and revise SOPs and quality documentation
- Partner cross-functionally with Manufacturing, Engineering, and Regulatory teams to maintain compliance with FDA and ISO 13485 requirements
What You Bring
- Bachelor’s degree in engineering, Quality, or a related technical field
- 2–5 years of quality engineering experience in an FDA-regulated manufacturing environment
- Hands-on experience developing or executing IQ/OQ/PQ or process-validation protocols
- Working knowledge of ISO 13485 and FDA quality system requirements
- Strong problem-solving skills and comfort working directly on a manufacturing floor
- ASQ certification (CQE) or Lean Six Sigma training a plus, not required
Compensation & Location Competitive salary and benefits package; based on-site in the greater Rochester, NY area. Relocation not provided. Local candidates preferred.
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